510(k) Report

Devices descending from DEN170073

128 later devices reach ContaCT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221248Rapid LVOIschemaview, Inc.20220—
+4K214043BriefCaseAidoc Medical, Ltd.20220—
+4K213566ClearRead Xray PneumothoraxRiverain Technologies, Inc.20220—
+4K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai20223—
+4K213319Viz ANEURYSM, Viz ANXViz. Ai, Inc.20222—
+4K211803HealthPPTZebra Medical Vision, Ltd.20210—
+4K211733Lunit INSIGHT CXR TriageLunit, Inc.20217—
+5K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.20260—
+5K261085Rapid Vessel Occlusion (Rapid VO)iSchemaview20260—
+5K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+5K251533Rapid Obstructive Hydrocephalus, Rapid OHIschemaview, Inc.20250—
+5K251983Brainomix 360 Triage StrokeBrainomix Limited20250—
+5K251406BriefCase-TriageAidoc Medical, Ltd.20252—
+5K243808Rayvolve PTX-PEAZmed20250—
+5K243548BriefCase-TriageAidoc Medical, Ltd.20240—
+5K232410SmartChestMilvue20240—
+5K240291Efai Cardiosuite Cta Acute Aortic Syndrome Assessment SystemEver Fortune.Ai, Co., Ltd.20240—
+5K231871Radify TriageEnvisionit Deepai, Ltd.20240—
+5K223754BraveCXBering, Ltd.20230—
+5K230899qXR-PTX-PEQure.Ai Technologies20231—
+5K230074Rapid Aneurysm Triage and NotificationIschemaview, Inc.20230—
+5K222179Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20231—
+5K222268Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+5K223443Viz AAAViz. Ai, Inc.20230—
+6K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…Aidoc Medical, Ltd.20260—
+6K252970BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical, Ltd.20260—
+6K250831Annalise EnterpriseAnnalise-Ai20250—
+6K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc.20240—